Recall record at a glance
| Official record | Z-1343-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Angiodynamics, Inc. |
| Report date | Mar 27, 2024 |
| Recall initiation date | Jan 30, 2024 |
| Quantity | 130 units |
| Location | Queensbury, NY, United States |
Official product description
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
Why the product was recalled
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Distribution information
Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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